Pancreatic CancerPhase 1NCT00033241
Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
A Phase 1 study testing erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by OSI Pharmaceuticals at 2 sites in United States.
Trial summary
RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with gemcitabine may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- erlotinib hydrochloride and gemcitabine hydrochloride
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- 23 Jul 2001to 22 Apr 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed locally advanced or metastatic epithelial carcinoma of the pancreas or other malignancy considered to be potentially responsive to gemcitabine
- Newly diagnosed or gemcitabine naive
- Measurable or evaluable disease
- Not amenable to surgical intervention due to medical contraindications or non-resectability of the tumor
- No islet cell tumors or other non-epithelial cell carcinomas of the pancreas
- No active CNS metastases or leptomeningeal disease
- Treated or asymptomatic brain metastases are allowed if on a stable dose of corticosteroids and/or there is no change in brain disease status for at least 4 weeks after related therapy (e.g., whole-brain radiotherapy)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 70-100%
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 2.0 mg/dL (except for documented Gilbert's syndrome)
- AST or ALT less than 2 times upper limit of normal (ULN) (no greater than 5 times ULN if hepatic obstruction or metastases present)
- Albumin at least 2.5 g/dL
Renal:
- Creatinine less than 1.5 times ULN OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No significant cardiovascular disease
- No history of congestive heart failure currently requiring therapy
- No ventricular arrhythmia requiring anti-arrhythmic therapy
- No severe conduction disturbances
- No angina pectoris requiring therapy
- No myocardial infarction within the past 6 months
Gastrointestinal:
- No significant gastrointestinal abnormalities including:
- Requirement for IV alimentation
- Active peptic ulcer disease
Ophthalmic:
- No significant ophthalmologic abnormalities including:
- Severe dry eye syndrome
- Keratoconjunctivitis sicca
- Sjogren's syndrome
- Severe exposure keratopathy
- Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis)
- Abnormal Schirmer test (less than 2 mm) allowed provided there is no evidence of clinically significant corneal surface abnormalities
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known or suspected hypersensitivity to gemcitabine
- No uncontrolled infection
- HIV negative
- No other malignancy within the past 5 years except treated non-melanoma skin cancer or carcinoma in situ of the breast or cervix
- No other life-threatening illness
- No psychiatric disorders or altered mental status the would preclude informed consent or study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 28 days since prior immunotherapy or biological response modified therapy for the primary malignancy
- No concurrent immunotherapy or biologic response modifier therapy for the primary malignancy
Chemotherapy:
- See Disease Characteristics
- At least 28 days since prior chemotherapy for the primary malignancy
- No prior mitomycin or nitrosoureas for the primary malignancy
- No more than 6 prior courses of chemotherapy with an alkylating agent for the primary malignancy
- No prior gemcitabine for the primary malignancy except as a low-dose (less than 500 mg/m^2) radiosensitizer administered concurrently with or within 2 weeks after radiotherapy at least 3 months ago
- No other concurrent chemotherapy for the primary malignancy
Endocrine therapy:
- See Disease Characteristics
- At least 28 days since prior systemic hormonal therapy (except LH-RH agonists) for the primary malignancy
- No concurrent systemic hormonal therapy (except LH-RH agonists) for the primary malignancy
- Other concurrent endocrine therapy is allowed as follows:
- Hormonal therapy (e.g., megestrol) for appetite stimulation
- Nasal, ophthalmic, or topical glucocorticoids
- Oral glucocorticoids for adrenal insufficiency
- Low-dose maintenance steroids
Radiotherapy:
- See Disease Characteristics
- At least 28 days since prior radiotherapy for the primary malignancy or metastases and recovered
- No prior wide-field radiotherapy to 25% or more of marrow-bearing bone
- No prior pelvic irradiation
- No concurrent radiotherapy for the primary malignancy or metastases
- No concurrent wide-field radiotherapy for pain management
Surgery:
- See Disease Characteristics
- Recovered from any prior surgery
- No prior surgical procedures affecting absorption
Other:
- No prior agent for the primary malignancy targeting the epidermal growth factor receptor (EGFR) or EGFR-specific tyrosine kinase activity
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cancer Therapy and Research Center
San Antonio, Texas, 78229-3271
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, 85724
About this study
Official title: A Phase Ib Multicenter Trial To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Gemcitabine Administered In Combination With Escalating Oral Doses Of OSI-774 To Patient Cohorts With Recently Diagnosed, Gemcitabine-Naive, Advanced Pancreatic Carcinoma Or Other Potentially Responsive Malignancies
RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with gemcitabine may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer or other solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of erlotinib in combination with gemcitabine in patients with recently diagnosed, gemcitabine-naive, locally advanced or metastatic pancreatic carcinoma or other potentially responsive solid tumor.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the objective antitumor response rate and response duration in patients treated with this regimen.
- Determine the time to disease progression and duration of overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of erlotinib.
Patients receive gemcitabine IV over 30 minutes on day 1 of weeks 1-7 and oral erlotinib once daily beginning on day 3 of week 1 and continuing for 8 weeks (course 1). Patients receive subsequent courses of therapy comprising gemcitabine once weekly for 3 weeks and erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are accrued and treated at the MTD as above.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 months.
- Being tested
- erlotinib hydrochloride, gemcitabine hydrochloride
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, unspecified adult solid tumor, protocol specific, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erlotinib hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start23 Jul 2001
- Primary completion22 Apr 2004
- Study completion22 Apr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- OSI Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Pedro Santabarbara, MD, Study chair, OSI Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033241
- Sponsor's protocol ID
- OSI-774-155
- Other IDs
- CDR0000069266, UARIZ-HSC-01128, NCI-V02-1694
- Status last verified
- Jun 2015
- First submitted
- 9 Apr 2002
- Last updated
- 10 Jan 2018
- Results posted
- No
Publications
Dragovich T, Patnaik A, Rowinsky EK, et al.: A phase I B trial of gemcitabine and erlotinib HCL in patients with advanced pancreatic adenocarcinoma and other potentially responsive malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-895, 2003.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Multicenter Trial To Determine The Safety, Tolerance And Preliminary Antineoplastic Activity Of Gemcitabine Administered In Combination With Escalating Oral Doses Of OSI-774 To Patient Cohorts With Recently Diagnosed, Gemcitabine-Naive, Advanced Pancreatic Carcinoma Or Other Potentially Responsive Malignancies
- ClinicalTrials.gov ID
- NCT00033241
- Acronym / sponsor ID
- OSI-774-155
- Keywords
- stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, unspecified adult solid tumor, protocol specific, stage IV pancreatic cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- OSI PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Jul 2001 (actual)
- Primary completion
- 22 Apr 2004 (actual)
- Study completion
- 22 Apr 2004 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with gemcitabine may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining erlotinib with gemcitabine in treating patients who have newly diagnosed locally advanced or metastatic pancreatic cancer or other solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose of erlotinib in combination with gemcitabine in patients with recently diagnosed, gemcitabine-naive, locally advanced or metastatic pancreatic carcinoma or other potentially responsive solid tumor.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the objective antitumor response rate and response duration in patients treated with this regimen.
- Determine the time to disease progression and duration of overall survival in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of erlotinib.
Patients receive gemcitabine IV over 30 minutes on day 1 of weeks 1-7 and oral erlotinib once daily beginning on day 3 of week 1 and continuing for 8 weeks (course 1). Patients receive subsequent courses of therapy comprising gemcitabine once weekly for 3 weeks and erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are accrued and treated at the MTD as above.
Patients are followed at 30 days.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| erlotinib hydrochloride | Drug | – |
| gemcitabine hydrochloride | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Results publicationDragovich T, Patnaik A, Rowinsky EK, et al.: A phase I B trial of gemcitabine and erlotinib HCL in patients with advanced pancreatic adenocarcinoma and other potentially responsive malignancies. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-895, 2003.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro Santabarbara, MD study chair
OSI Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing erlotinib hydrochloride and gemcitabine hydrochloride in people with Pancreatic Cancer and Unspecified Adult Solid Tumor, Protocol Specific, run by OSI Pharmaceuticals at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00033241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.